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Safety of Re-dosing Nirsevimab Prior to RSV Season 2 in Children With Heart or Lung Disease

Joseph B Domachowske1, Yue Chang2, Victoria Atanasova3

  • 1Department of Pediatrics, SUNY Upstate Medical University, Syracuse, New York, USA.

Journal of the Pediatric Infectious Diseases Society
|July 19, 2023
PubMed

Insights

Nirsevimab demonstrated a safety profile comparable to palivizumab in infants with congenital heart or chronic lung disease during their second respiratory syncytial virus (RSV) season. The drug exposure levels support its efficacy in preventing severe RSV disease in this high-risk group.

Area of Science:

  • Pediatrics
  • Infectious Diseases
  • Immunology

Background:

  • Infants with congenital heart disease (CHD) and/or chronic lung disease (CLD) face increased risk of severe respiratory syncytial virus (RSV) disease.
  • The second RSV season poses a continued threat to these vulnerable children.

Purpose of the Study:

  • To evaluate the safety and efficacy of nirsevimab in infants with CHD and/or CLD entering their second RSV season.
  • To assess nirsevimab serum exposures in this at-risk population.

Main Methods:

  • A study involving children with CHD and/or CLD entering their second RSV season.
  • Administration of 200 mg nirsevimab.
  • Comparison of safety profile with palivizumab.
  • Measurement of nirsevimab serum exposures.

Main Results:

  • Nirsevimab exhibited a similar safety profile to palivizumab in the studied population.
  • Nirsevimab serum exposures were achieved, correlating with efficacy observed in healthy infants.
  • These findings suggest potential efficacy against severe RSV disease in this high-risk group.

Conclusions:

  • Nirsevimab is a potential therapeutic option for preventing severe RSV disease in infants with CHD and/or CLD.
  • The safety and exposure profile supports its use in this vulnerable population.
  • Further research may confirm nirsevimab's efficacy in preventing RSV hospitalization and severe outcomes.

Keywords:
monoclonal antibodynirsevimabpalivizumabpharmacokineticsrespiratory syncytial virus

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